Gastric calibration tube

ABSTRACT

A gastric calibration tube includes a flexible elongate member, a pushing member, and a balloon member. The flexible elongate member has a proximal end portion, a distal end portion, and an outer surface that extends between the proximal and distal end portions. The outer surface defines a side opening. The flexible elongate member defines a lumen that is in communication with the side opening. The pushing member has a proximal portion and a distal portion. The distal portion is advanceable through the lumen of the flexible elongate member and out of the side opening of the flexible elongate member. The balloon member is secured to one or both of the flexible elongate member and the pushing member. The balloon member is inflatable to fix the gastric calibration tube within a patient&#39;s stomach.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a Divisional Application which claims thatbenefit of and priority to U.S. patent application Ser. No. 14/169,430,filed on Jan. 31, 2014, (now U.S. Pat. No. 9,775,735) the entire contentof which is incorporated herein by reference.

TECHNICAL FIELD

The present disclosure generally relates to surgical tools, and moreparticularly, to gastric calibration tubes used in bariatric procedures.

BACKGROUND

A gastric calibration tube is a surgical tool used to effectuate asurgical procedure on a patient's stomach in an effort to reduceexcessive obesity in the patient. In use, the tube is advanced into apatient's body through an oral cavity and down through the esophagusinto the stomach to provide delineation of the antrum of the stomach,irrigation/suction of fluids, and/or a sizing of a gastric pouch. Whilebeing advanced, due at least in part to the circuitous nature of thistrack, a clinician may need to reposition the tube in variousorientations until the tube is properly aligned or bypasses anyobstruction(s). Increasing maneuverability of the tube can reduce thetime to perform a desired procedure.

SUMMARY

According to one aspect of the present disclosure, a gastric calibrationtube includes a flexible elongate member, a pushing member, and aballoon member which provides ease of maneuverability and no proceduralchange from current procedures.

The flexible elongate member is dimensioned to extend between apatient's stomach and an oral cavity of the patient. The flexibleelongate member has a proximal end portion, a distal end portion, and anouter surface that extends between the proximal and distal end portions.The outer surface defines a side opening. The flexible elongate memberdefines a lumen that is in communication with the side opening.

The flexible elongate member can include a reference indicator to enablea user to identify an orientation of the side opening. In someembodiments, the reference indicator is positioned proximally offsetfrom the side opening. The reference indicator can be positioned inregistration with the side opening.

The flexible elongate member defines a launch curve dimensioned todirect the pushing member through the side opening of the flexibleelongate.

In certain embodiments, the distal end portion of the flexible elongatemember is solid. The distal end portion of the flexible elongate membercan define an aspiration lumen that extends distally to an openingdefined in a distal end of the distal end portion.

The pushing member has a proximal portion and a distal portion. Thedistal portion is advanceable through the lumen of the flexible elongatemember and out of the side opening of the flexible elongate member. Theproximal portion of the pushing member is disposed within the lumen ofthe flexible elongate member as the distal portion of the pushing memberis advanced out of the side opening of the flexible elongate member.

The balloon member is secured to at least one of the flexible elongatemember and the pushing member. The balloon member is inflatable to fixthe gastric calibration tube within a patient's stomach.

In some embodiments, the flexible elongate member defines a lumen influid communication with at least one of a fluid source and a vacuumsource.

In certain embodiments, the flexible elongate member includes at leastone depth marking.

According to another aspect, the elongate member defines a launch curvebetween the proximal end portion and the distal end portion. Theproximal end portion and the launch curve can define a lumen incommunication with a side opening defined in an outer surface of theproximal end portion. In some embodiments, the pushing member ispositioned within the lumen of the elongate member and pushing membermovable through the lumen and out of the side opening.

In certain embodiments, the pushing member curves as the pushing memberslides along the launch curve and out of the side opening. Both theelongate member and pushing member can be formed of a flexible material.

According to yet another aspect, a method for advancing a gastriccalibration tube includes advancing an elongate member through an oralcavity toward a stomach of a patient, selectively advancing a pushingmember through the elongate member and out of a side opening defined inan outer surface of the elongate member to move the elongate member, andinflating a balloon supported on the elongate member in the stomach ofthe patient. The method can involve positioning the balloon within theantrum of the stomach. The method can include aspirating fluid withinthe stomach through the elongate member. The method can involveorienting the side opening of the elongate member with a referenceindicator supported on the elongate member.

Other aspects, features, and advantages will be apparent from thedescription, the drawings, and the claims.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and constitute apart of this specification, illustrate embodiments of the disclosureand, together with a general description of the disclosure given above,and the detailed description of the embodiment(s) given below, serve toexplain the principles of the disclosure, wherein:

FIG. 1A is a side, cross-sectional view of a leading end portion of oneillustrative embodiment of a gastric calibration tube shown coupled to afluid source and a vacuum source in accordance with the principles ofthe present disclosure;

FIG. 1B is a side view of a portion of the gastric calibration tube ofFIG. 1A;

FIGS. 2 and 3 are progressive, side, cross-sectional views of thegastric calibration tube of FIG. 1A navigating through an esophagus;

FIGS. 4 and 5 are progressive side views of the gastric calibration tubeof FIG. 1A aspirating bodily fluid from within a stomach.

FIG. 6 is a side view of the gastric calibration tube of FIG. 1A shownsecured to the stomach;

FIG. 7 is a side, cross-sectional view of a leading end portion ofanother illustrative embodiment of a gastric calibration tube showncoupled to a fluid source and a vacuum source in accordance with theprinciples of the present disclosure;

FIGS. 8-10 are progressive, side views of the gastric calibration tubeembodiment of FIG. 7 which illustrate the tube aspirating bodily fluidfrom within a stomach and securement of the tube to a patient's stomach;

FIG. 11 is a side, partial cross-sectional view of a leading end portionof still another illustrative embodiment of a gastric calibration tubeshown coupled to a fluid source and a vacuum source in accordance withthe principles of the present disclosure;

FIGS. 12-14 are progressive, side, partial cross-sectional views of thegastric calibration tube of FIG. 11 navigating through an esophagus; and

FIGS. 15-18 are progressive side views of the gastric calibration tubeembodiment of FIG. 11, which illustrate aspirating bodily fluid fromwithin a stomach and securement of the tube to the stomach.

DETAILED DESCRIPTION

As used herein, the term “clinician” refers to a doctor, nurse, or othercare provider and may include support personnel. The terms “proximal” or“trailing” each refer to the portion of a structure closer to aclinician, and the terms “distal” or “leading” each refer to a portionof a structure farther from the clinician.

Referring now to FIG. 1A, a gastric calibration tube 100 includes anelongate member 110, a balloon member 120 supported on the elongatemember 110, and a pushing member 130 supported within the elongatemember 110. It should be appreciated that, as used herein, the termballoon member refers to any structure defining a volume that isexpandable upon introduction of fluid into the volume and, thus, caninclude a unitary arrangement of material and/or a multi-componentarrangement secured together to form, for example, a bladder.

In use, as described in further detail below with reference to FIGS.2-6, the gastric calibration tube 100 is insertable into an oral cavity(e.g., a mouth) of a patient and is advanceable distally (e.g.,caudally) along a track that extends between an oral cavity and astomach of the patient. If the gastric calibration tube 100 encountersan obstruction or otherwise become misaligned during advancement alongthe track, the pushing member 130 is adapted to advance out of theelongate member 110 and into engagement with a surface of a structurealong the track (e.g., a wall of the esophagus) to drive the elongatemember 110 away from the obstruction or back into alignment so that theelongate member 110 can be further advanced. When positioned in thestomach of the patient (e.g., the antrum or lower part of the stomach),the balloon 120 can be inflated to fix the gastric calibration tube 100within the stomach and aid a clinician in performing a bariatricsurgical procedure such as sleeve gastrectomy.

Referring again to FIG. 1A, the elongate member 110 can be formed of anymaterial with sufficient flexibility to enable the elongate member 110to maneuver along the patient's track between the oral cavity and thestomach. The elongate member 110 includes a leading end portion 110 aand a trailing end portion 110 b and defines a centerline “A” thatextends between the leading and trailing end portions 110 a, 110 b.

The leading end portion 110 a includes a distal tip 112. The distal tip112 can be formed of any material that is solid or substantially solid.The distal tip 112 defines an aspiration lumen 114 that extends betweena distal opening 114 a defined in a leading end of the distal tip 112and a proximal opening 114 b defined in a trailing end of the distal tip112. In some embodiments, as described in greater detail below, theaspiration lumen 114 extends along a length of the elongate member 110.

The elongate member 110 defines a lumen 116 that extends from thetrailing end portion 110 b to the trailing end of the distal tip 112.The lumen 116 is in fluid communication with a side opening 116 adefined in an outer surface of the trailing end portion 110 b. At leasta portion of the lumen 116 (e.g., a leading end portion of the lumen116) can be curved. A launch curve 116 b is defined between a leadingend of the trailing end portion 110 b and a trailing end of the leadingend portion 110 a. More particularly, the launch curve 116 b can be acurvature of the trailing end of the distal tip 112. As appreciated, thelaunch curve 116 b can have any suitable geometry including any suitableradius of curvature. In some embodiments, the launch curve 116 b definesa distal curvature of the lumen 116.

An inflation lumen 118 is defined in the elongate member 110 that is influid communication with an opening 118 a defined in an outer surface ofthe distal tip 112. The balloon member 120 is supported on the outersurface of the distal tip 112 over the opening 118 a. The balloon member120 is adapted to receive inflation fluid (e.g., saline) through theinflation lumen 118 when the inflation lumen 118 is coupled to a fluidsource 140 adapted to deliver the inflation fluid. Alternatively, and/oradditionally, the inflation lumen 118 couples to a vacuum source 150adapted to create a vacuum in the inflation lumen 118 to draw inflationfluid within the balloon member 120 out of the balloon member to deflatethe balloon member 120. As appreciated, the fluid and/or vacuum sources140, 150 enable a clinician to control the size of the balloon member120 as desired.

The vacuum source 150 couples to the aspiration lumen 114 in the distaltip 112 to aspirate bodily fluids out of a surgical site such as theantrum of the stomach. As shown, the aspiration lumen 114 is in fluidcommunication with the lumen 116 so that aspirated bodily fluids willpass through the aspiration lumen 114 and the lumen 116. The sideopening 116 a functions as an inlet that draws bodily fluids in when thelumen 116 is coupled to a vacuum source 150. In some embodiments, theaspiration lumen 114 is defined along a length of the elongate member110 and is separate from the lumen 116. In certain embodiments, theaspiration lumen 114 can extend from the distal end of the distal tip112 (or any suitable location along the distal tip 112) to an exitlocation anywhere along the length of the trailing end portion 110 bincluding a proximal end of the trailing end portion 110 b.

A reference indicator 160 can be included on an outer surface of theelongate member 110 at a location on the elongate member 110 thatenables a clinician to identify the location and/or orientation of theside opening 116 a. More particularly, the reference indicator 160functions as a reference to orient the elongate member 110 so that thepushing member 130 can advance along the launch curve 116 b and outthrough the side opening 116 a in any suitable direction as desired. Itshould be appreciated, that the pushing member 130 has an elongate bodyand can be formed of any suitable material with sufficient flexibilityto enable the pushing member 130 to be directed by the launch curve 116b and out of the side opening 116 a. In certain embodiments, asillustrated in FIG. 1B, the elongate member 110 includes one or moredepth markings 170 on the outer surface of the elongate member 110 thatfunction as an indicator for an insertion depth of the gastriccalibration tube 100 along the track of the patient.

In an exemplary use, as illustrated in FIGS. 2-3, the gastriccalibration tube 100 is insertable into a patient and is distallyadvanceable toward the stomach down a track that extends along theesophagus “E.” Upon encountering an obstruction or becoming misaligned,for example, when the distal tip 112 of the gastric calibration tube 100is frictionally restricted by curvature in the esophagus “E” at a pointof restriction “R” that inhibits the gastric calibration tube 100 fromdistally advancing through the esophagus “E,” the pushing member 130 canadvance through lumen 116 into engagement with the launch curve 116 b.As depicted in FIG. 3, the launch curve 116 b directs the pushing member130 out through the side opening 116 a so that the pushing member 130extends out from an outer surface of the elongate member 100 and intoengagement with a surface such as an inner surface of the esophagus “E.”An opposing reaction force, which results from the engagement between adistal end of the pushing member 130 and the surface of the esophagus“E,” urges the elongate member 110 away from the obstruction or point ofrestriction “R.” Upon moving the gastric calibration tube 100 away fromthe obstruction/point of restriction “R” and/or otherwise realigning thegastric calibration tube as desired, the pushing member 130 can be drawnback into the gastric calibration tube 100 and the gastric calibrationtube 100 can be further distally advanced (e.g., past the obstructionand/or point of restriction “R”).

Referring to FIGS. 4-6, upon positioning the gastric calibration tube100 into the stomach “S,” the vacuum source 150 functions to aspiratebodily fluid “F” in the stomach “S.” In particular, a vacuum created inthe aspiration lumen 114 draws the bodily fluid “F” into the distalopening 114 a of the distal tip 112 for proximal extraction of thebodily fluid “F” through the aspiration lumen 114 (see FIG. 5). As canbe appreciated, the vacuum source 150 can also function to collapse thestomach or portions thereof to facilitate any suitable bariatricprocedure such as sleeve gastrectomy.

As shown in FIG. 6, the pushing member 130 can be advanced out throughthe side opening 116 a of the elongate member 110 so that launch curve116 b directs the pushing member 130 into engagement with an innersurface of the stomach “S” to urge the elongate member 110 toward anydesirable location within the stomach “S” for inflating the balloonmember 120 and/or for applying irrigation/aspiration within the stomach“S.” For example, reaction force resulting from engagement of thepushing member 120 with the inner surface of the stomach “S” positionsthe elongate member 110 adjacent the antrum of the stomach “S” so thatthe balloon member 120 can be inflated within the antrum.

It should be appreciated that the inflation source 140 couples to thegastric calibration tube 100 to partially and/or wholly inflate theballoon 120 to fix the gastric calibration tube 100 within the stomach“S” (e.g., the antrum) and aid the clinician in performing the bariatricsurgical procedure. For example, in a sleeve gastrectomy procedure, withthe balloon 120 inflated in the antrum of the stomach, a clinician canremove a large portion of the stomach and staple the remaining portiontogether to limit the size of the patient's stomach for helping thepatient lose weight.

Referring now to FIG. 7, another embodiment of a gastric calibrationtube, generally referred to as gastric calibration tube 200, is shown.Gastric calibration tube 200 is substantially similar to gastriccalibration tube 100 and is only described herein to the extentnecessary to describe the differences in construction and operation ofthe gastric calibration tube 200. In general, the gastric calibrationtube 200 includes an elongate member 210, a pushing member 220, andoperably couples to one or both of the fluid source 140 and the vacuumsource 150.

The elongate member 210 includes a distal tip 212 and defines anaspiration lumen 214 and a lumen 216. The aspiration lumen 214 extendsto a distal opening 214 a defined in the distal tip 212. An outersurface of the elongate member 210 defines a side opening 216 a that isin fluid communication with the lumen 216. In some embodiments, theelongate member 210 includes a reference indicator 218 that ispositioned on the outer surface of the elongate member 210 inregistration with the side opening 216 a. Similar to reference indicator160 of the gastric calibration tube 100, reference indicator 218functions to identify the location and/or orientation of the sideopening 216 a to facilitate deployment accuracy of the pushing member220 into a desired surgical site. Although not shown, the elongatemember 210 can also include one or more depth markings similar to thoseshown in FIG. 1B.

The pushing member 220 has an elongate body that supports an inflatableballoon 222 on an outer surface of a distal end portion of the pushingmember 220. The pushing member 220 defines an inflation lumen 224 influid communication with the inflatable balloon 222 to enable theballoon 222 to receive inflation fluid (e.g., saline) when the inflationlumen 224 is in fluid communication with the fluid source 140.

In an exemplary use of the gastric calibration tube 200, the pushingmember 220 functions to enable the gastric calibration tube 200 tobypass an obstruction and/or point of restriction “R” as described abovewith respect to the pushing member 130 of the gastric calibration tube100.

With reference to FIG. 8, when the gastric calibration tube 200 ispositioned in the stomach “S,” the vacuum source 150 can function toaspirate bodily fluid “F” from within the stomach “S” as described abovewith respect to gastric calibration tube 100. More particularly, thevacuum source 150 creates a vacuum in the aspiration lumen 214 and drawsthe bodily fluid “F” into the distal opening 214 a for proximalextraction.

Referring also to FIGS. 9-10, the pushing member 220 can be advanced outof the side opening 216 a and positioned at any suitable location in thestomach “S.” As appreciated, when in fluid communication with theballoon 222 supported on the pushing member 220, the inflation source140 can function to partially and/or wholly inflate the balloon 222 tofix the gastric calibration tube 200 within the stomach “S” as necessaryto aid the clinician in performing a bariatric surgical procedure.

Referring now to FIG. 11, another embodiment of a gastric calibrationtube, generally referred to as gastric calibration tube 300, is shown.Gastric calibration tube 300 is substantially similar to gastriccalibration tubes 100 and 200 and is only described herein to the extentnecessary to describe the differences in construction and operation ofthe gastric calibration tube 300. In general, the gastric calibrationtube 300 includes an elongate member 302 that supports a first balloon304 and a second balloon 306 and operably couples to one or both of thefluid source 140 and the vacuum source 150. The second balloon 306 canfunction in a similar manner to the pushing member 130 of the gastriccalibration tube 100.

The elongate member 302 defines a first lumen 308 in fluid communicationwith the first balloon 304 and a second lumen 310 in fluid communicationwith the second balloon 306. As shown in FIG. 11, the elongate member302 defines an aspiration lumen 312 that is in fluid communication witha side opening 314 defined in an outer surface of the elongate member302 at a distal end portion of the elongate member 302. In certainembodiments, the elongate member 302 includes one or more depth markings316 on an outer surface of the elongate member 302 similar to the depthmarking shown in FIG. 1B. A first connector 318 a and a second connector318 b are secured to the outer surface of the elongate member 302. Incertain embodiments, one or both of the first and second connectors 318a, 318 b are luer connectors or any other suitable connector known inthe art. The first connector 318 a is in fluid communication with lumen310 and the second connector 318 b is in fluid communication with lumen308. One or both of the fluid source 140 and the vacuum source 150couple to one or both of the first and second connectors 318 a, 318 b byany suitable connection 320 coupled to the respective fluid and/orvacuum source 140, 150.

In use, with reference to FIGS. 12-14, the gastric calibration tube 300is inserted into an oral cavity of a patient and advanced along thetrack through the esophagus “E” toward the patient's stomach “S.” If thegastric calibration tube 300 encounters an obstruction or otherwisebecomes misaligned while being advanced along the track, the secondballoon 306 can be inflated (e.g., via the inflation fluid “IF” from thefluid source 140 such as saline).

During inflation, the second balloon 306 extends substantially laterallyoutwardly from the outer surface of the elongate member 302. The secondballoon 306 is expandable to a dimension large enough to apply anexpansion force to a surface of a structure along the track such as theinner surface of the esophagus “E.” A reaction force responsive to theexpansion force urges the elongate member 302 away from theobstruction/point of restriction “R,” and/or otherwise realigns theelongate member 302 as desired.

The vacuum source 150 couples to the connector 318 a so that theinflation fluid “IF” (e.g., saline) can be withdrawn from the secondballoon 306 to deflate the second balloon 306 can be deflated tofacilitate distal advancement of the elongate member 110.

Turning now to FIGS. 15-16, the vacuum source 150 can be positioned influid communication with the aspiration lumen 312 and used to aspiratebodily fluid “F” in the stomach “S” into the side opening 314 of thegastric calibration tube 300 for proximal extraction (see FIG. 16)therethrough as described above with regard to gastric calibration tube100.

As shown in FIG. 17, the fluid source 140 couples to the connector 318 aso that the second balloon 306 can be inflated into engagement with aninner surface of the stomach “S” to urge a leading end portion of thegastric calibration tube 300 toward any desirable location within thestomach “S” for inflating the first balloon 304 and/or for applyingirrigation/aspiration within the stomach “S” (e.g., by virtue of theside opening 314). For example, reaction force resulting from engagementof the second balloon 306 with the inner surface of the stomach “S”positions the leading end portion of the gastric calibration tube 300adjacent to the antrum of the stomach “S” so that the first balloonmember 304 can be inflated within the antrum to fix the gastriccalibration tube 300 within the stomach “S.”

As shown in FIG. 18, the fluid source 140 couples to the connector 318 bso that the first balloon 304 can be inflated to fix the gastriccalibration tube 300 within the stomach “S” as described above withregard to the balloon 120 of the gastric calibration tube 100.

Persons skilled in the art will understand that the structures andmethods specifically described herein and shown in the accompanyingfigures are non-limiting exemplary embodiments, and that thedescription, disclosure, and figures should be construed merely asexemplary of particular embodiments. It is to be understood, therefore,that the present disclosure is not limited to the precise embodimentsdescribed, and that various other changes and modifications may beeffected by one skilled in the art without departing from the scope orspirit of the disclosure. Additionally, the elements and features shownor described in connection with certain embodiments may be combined withthe elements and features of certain other embodiments without departingfrom the scope of the present disclosure, and that such modificationsand variations are also included within the scope of the presentdisclosure. Accordingly, the subject matter of the present disclosure isnot limited by what has been particularly shown and described.

What is claimed is:
 1. A gastric calibration tube, comprising: aflexible elongate member defining a side opening and a lumen that is incommunication with the side opening, the flexible elongate member havinga distal end portion defining an aspiration lumen that extends distallyto an opening defined in a distal end of the distal end portion; apushing member configured to advance through the lumen of the flexibleelongate member and out of the side opening of the flexible elongatemember; and a balloon member secured to the pushing member andconfigured to maintain the gastric calibration tube within a patient'sstomach.
 2. A gastric calibration tube, comprising: a flexible elongatemember having a proximal end portion, a distal end portion, and an outersurface that extends between the proximal and distal end portions, theouter surface defining a side opening, the distal end portion definingan aspiration lumen that extends distally to an opening defined in adistal end of the distal end portion, the flexible elongate memberincluding a launch curve and defining a lumen that are in communicationwith the side opening; a pushing member having a proximal portion and adistal portion, the distal portion being advanceable through the lumenof the flexible elongate member so that the launch curve of the flexibleelongate member can direct the distal portion of the pushing member outof the side opening of the flexible elongate member; and a balloonmember secured to at least one of the flexible elongate member and thepushing member, the balloon member being inflatable to fix the gastriccalibration tube within a patient's stomach.
 3. A method for advancing agastric calibration tube, the method comprising: advancing an elongatemember through an oral cavity toward a stomach of a patient; selectivelyadvancing a pushing member through the elongate member and out of a sideopening defined in an outer surface of the elongate member; aspiratingfluid within the stomach through an aspiration lumen defined in a distalend portion of the elongate member, the aspiration lumen extendingdistally to an opening defined in a distal end of the distal endportion; and inflating a balloon supported on the pushing member in thestomach of the patient.
 4. The method of claim 3, further includingpositioning the balloon within the antrum of the stomach.
 5. The methodof claim 3, further including orienting the side opening of the elongatemember with a reference indicator supported on the elongate member. 6.The gastric calibration tube of claim 2, wherein the lumen is in fluidcommunication with at least one of a fluid source and a vacuum source.7. The gastric calibration tube of claim 2, wherein the flexibleelongate member includes at least one depth marking.
 8. The gastriccalibration tube of claim 2, wherein the flexible elongate memberincludes a reference indicator that identifies an orientation of theside opening.
 9. The gastric calibration tube of claim 8, wherein thereference indicator is positioned proximally offset from the sideopening.
 10. The gastric calibration tube of claim 2, wherein theaspiration lumen extends through the launch curve to communicate withthe lumen of the flexible elongate member through which the pushingmember advances.
 11. The gastric calibration tube of claim 1, whereinthe aspiration lumen extends through a launch curve of the flexibleelongate member to communicate with the lumen of the flexible elongatemember through which the pushing member advances.